Smoking Cessation
Conditions
Brief summary
Pilot study of a new nicotine replacement therapy for smoking cessation.
Detailed description
This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.
Interventions
DRUGNicotine replacement therapy
Nicotine replacement therapy with Standard NRT user direction
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older male and female cigarette smokers motivated and willing to stop smoking * female participants of child-bearing potential should use a medically acceptable means of birth control * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate
Exclusion criteria
* unstable angina pectoris or myocardial infarction during the previous 3 months * pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential) * participation in other clinical trials within the previous three months and during study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean hourly and daily number of doses used | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Ratings of craving/urge to smoke and withdrawal symptoms | Day 1-14, and Day 20 |
| Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm | Day 1-21 |
| Mean number of NRT use occasions per day | Week 1, 2, and 3 |
| Product acceptability | At week 3 visit |
| Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product. | throughout duration of the study (+ 30 days for spontaneous SAEs) |
| Cotinine levels | At baseline and week 3 |
Countries
United Kingdom
Outcome results
None listed